http://www.unison.ie/irish_independent/index.php3?ca=9&si=462435&issue_id=4755

 

Drugs firm withheld key results of vaccine test

 

PHARMACEUTICAL giant Wellcome withheld damaging information about highly reactive batches of the 3-in-1 infant vaccine from the Irish health authorities.

The multinational company, which has since merged to become Glaxo Smith Kline, is at the centre of the controversy surrounding the inadvertent injection of some children in Dublin with the veterinary vaccine, Tribovax T rather than the 3-in-1 vaccine, Trivax in 1973.

The late 1960s and early 70s were a period of greatly increased numbers of adverse reactions in both Ireland and Britain.

In August 1973 the Eastern Health Board expressed its serious concern directly to Wellcome. The EHB drew specific attention to five lots of vaccine from which reactions were appearing most regularly.

The information was sent to the Head of Wellcome's Clinical Immunology Department, Dr AH Griffith who forwarded it to a senior colleague seeking precise details.

A couple of weeks later the results of tests carried out on the lots were relayed to Dr Griffith.

In a memo, thanking his colleague for the results, Dr Griffith said: "I am not sure whether they imply that these batches are abnormally reactogenic or whether, on intensive study, all batches are highly reactogenic.

"There seems to be no point in forwarding information to Dublin at this stage ... "

The following week Dr Griffith wrote back to the EHB stating that he was trying to find a reason why there should be higher reactogenicity in Dublin than elsewhere.

He concluded: "I have received information on the batches of vaccine sent to you but that reveals nothing abnormal."

The information that had been despatched by the EHB to Wellcome included more than 80 detailed cases of adverse reactions noted at health clinics in Dublin in the first half of 1973.

Under a reciprocal arrangement with the National Drugs Advisory Board, Wellcome was due to furnish twice-yearly reports of vaccine reactions to the NDAB. But the Irish Medicines Board, which succeeded the NDAB, has confirmed that only two adverse reactions to the 3-in-1 vaccine Trivax were notified to it in 1973.

In the course of his correspondence with the EHB in August, 73, Dr Griffith had also pointed out that it was significant that between 1964 and 1971, not a single case of hypsarrhythmia (loosely described as high voltage activity in the brain) or infantile spasms were among reactions to DTP (the 3-in-1 vaccine) reported to the UK Committee on Safety in Medicines.

But details of the reactions reported to that Committee during this period included convulsions, screaming attacks, post-encephalitic muscle weakness, an angioneurotic oedema and two deaths.

Last night the Glaxo Smith Kline Corporation was considering these latest revelations.

Yesterday's revelations in the Irish Independent sparked a series of investigations. Health Minister Micheal Martin, in a heated Dail debate, said he was "concerned to get fast answers from those concerned".

And he said if they did not get answers they would have to consider what options they had.

He told how his department contacted the Irish Medicines Board and it was concentrating on securing information from the company. The Board said it had no prior knowledge of an "alleged inadvertent use" of Tribovax T in place of Trivax.

Brian McDonald

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